The FDA’s Science Board yesterday agreed to form a new subcommittee to help the agency examine 3 specified domains of regulatory science activities related to medical devices, assess progress made since 2007, and address the challenges posed by rapidly evolving science and technology.

These challenges include the scientific implications of the increasing globalization of product development and supply chains, the federal watchdog agency noted in background materials released ahead of the meeting.

The FDA specifically requested that the new subcommittee make its recommendations with the agency’s current staff and financial resources in mind, but also welcomed additional recommendations for steps the agency could take if new, additional resources for regulatory science are made available.

The new subcommittee will assess FDA’s progress since 2007, when "FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology" was released. That report found that "the demands on the FDA have soared … and the resources have not increased in proportion to the demands."

The previous subcommittee called for strategic leadership and support, including new resources; for strengthening science at FDA, with particular attention to emerging technologies; and for strengthening professional development, according to the agency.

The new subcommittee will provide feedback on how well the FDA’s "Strategic Plan for Regulatory Science" captures FDA’s cross-cutting scientific needs and whether modifications should be made to the plan. It will also recommend additional steps FDA could take to best position itself to meet emerging and future trends in science, technology and FDA-regulated products.

The subcommittee is also tasked with suggesting how the FDA can better collaborate with public and private sector entities, suggest strategies and frameworks for collaboration, and recommend potential new collaborations to advance the agency’s mission, the agency said.

And the new subcommittee will provide feedback on FDA’s activities in recent years to "foster an environment of scientific excellence" and make suggestions for what additional steps the agency could take to further support such a culture.

The safety bureau expects to provide the new subcommittee with a progress report that includes specific questions for input within a year, according to chief scientist Dr. Jesse Goodman.

Financial and strategic threats to FDA’s device branch

A draft report published ahead of the meeting, "Protecting the core of CDRH regulatory science in the face of financial and strategic threats," summarizes how FDA’s device branch, the Center for Devices & Radiological Health, can function most efficiently, but warns against cost-cutting.

"Loss in federal investment in regulatory science at CDRH will interfere with the regulatory approval of emerging technologies and in doing so cost lives," according to the report. "With the medical device industry setting a record pace in advancing life-saving technology, there is no more pressing need at the FDA than to fund fully a robust and successful CDRH regulatory science program."

The report details several threats to the success of the device branch, including the FDA’s ability to keep up on technological advances, a political environment that limits the resources available for scientific growth within the CDRH, and a limited science staff.

The report also makes several specific recommendations related to the CDRH’s mission and scope, the branch’s organization, and how to enhance advocacy, communication, collaboration and funding for the agency’s device branch.

The medical device center’s primary research mission should be to foster science and engineering with a clear link to regulatory challenges, the Science Board states.

"Every project, laboratory and division should be completely aligned to this mission that no other government agency has," according to the board.

Better public understanding of the CDRH’s critical role in conducting research is needed. This can be gained through heightened visibility, enhanced by research collaborations and educational efforts, the report concludes.

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Editor’s Note: This article is written by Ashley Boam and Mary Malarkey from the “FDA Voice” blog. Boam is an FDA’s acting Director of the Office of Policy for Pharmaceutical Quality, the Office of Pharmaceutical Quality and the Center for Drug Evaluation and Research. Malarkey is an FDA’s Director if the Office of Compliance and Biologics Quality […]